Dexmedetomidine, sold under the trade name precedex among others, is an anxiety reducing, sedative, and pain medication. Dexmedetomidine hydrochloride injection, solution dailymed. The dexmedetomidine is salified in hydrochloric acid to obtain. Dexmedetomidine is an imidazole derivate and active disomer of medetomidine with analgesic, anxiolytic and sedative properties. Dexmedetomidine hydrochloride injection, usp mylan adds dexmedetomidine hydrochloride injection, usp to its product portfolio, arming hospitals, clinics and other health systems with the therapies they need. In group dv n 45, sedation was performed with dexmedetomidine hydrochloride precedex. Dexmedetomidine hydrochloride supplier cas 145108583. Precedex infusion should not be coadministered through the same intravenous catheter with blood or plasma because physical compatibility has not been established.
Dexmedetomidine hydrochloride united states pharmacopeia. What dexmedetomidine ever pharma looks like and contents of the pack. Federal law restricts this drug to use by or on the order of a licensed veterinarian. This product information is intended only for residents of the united states. Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Dexmedetomidine hydrochloride as a longterm sedative. Official label printer friendly view all sections close all sections. Dexmedetomidine is an alpha2 agonist, a novel sedative with analgesic properties that controls stress, anxiety and pain with stable respiratory rates, and predictable cardiovascular and respiratory. Each 10 ml vial contains micrograms of dexmedetomidine as hydrochloride.
Dexmedetomidine is notable for its ability to provide sedation without risk of respiratory depression unlike other commonly used drugs such as propofol and fentanyl and can provide cooperative or semirousable sedation. Dexmedetomidine is a relatively new drug to the uk having been launched in october 2011 with marketing authorization for sedation of adult intensive care unit. Canadian regulations limit the scope of information we are permitted to give on prescription drugs via the internet or other means. In addition, 44% 79 of 178 patients of dexmedetomidine hydrochloride patients received no morphine sulfate for pain versus 19% 33 of 175 patients in the placebo group. Efficacy of dexmedetomidine for treatment of patients with. Dexmedetomidine hydrochloride is used clinically as an anesthetic agent to reduce anxiety and tension and promote relaxation and sedation without causing respiratory depression. List of drug master files dmf of dexmedetomidine hydrochloride active pharmaceutical ingredient api submitted to the u. The invention provides a new method for preparing dexmedetomidine hydrochloride. Dexmedetomidine why should i make it a part of my anaesthetic practice. Welcome to the dexmedetomidine source, an interactive internet site designed to provide information to physicians and healthcare personnel about dexmedetomidine hydrochloride injection precedex, a novel therapeutic modality approved by the us food and drug administration fda in december 1999 for sedation in patients hospitalized in intensive care settings. Dexmedetomidine hydrochloride injection, concentrate fda. Precedex dexmedetomidine hydrochloride for injection and dexmedetomidine injection is indicated for. Dexmedetomidine hydrochloride injection should be administered only by persons skilled in the management of patients in the operating room setting. Dexmedetomidine hydrochloride has a good analgesic effect in intraoperative anaesthesia during brainstem tumour surgery, which significantly.
Precedex infusion should not be coadministered through the same intravenous catheter with blood. Sublingual dexmedetomidine compositions and methods of use thereof download pdf info publication number kr20120008058a. Dexmedesed dexmedetomidine hydrochloride is a synthetic alpha 2adrenoreceptor agonist with sedative and analgesic properties. Dexmedetomidine selectively binds to presynaptic alpha2 adrenoceptors located in the brain, thereby inhibiting the release of norepinephrine from synaptic vesicles. Dexmedetomidine selectively binds to and activates presynaptic alpha2 adrenoceptors located in the brain, thereby inhibiting the release of norepinephrine from synaptic vesicles. This material safety data sheet does not constitute the guaranty or specifications of the product. According to the method, lewis acid is used as a catalyst, and racemized medetomidine is prepared by a friedelcrafts reaction. In this study, dexmedetomidine hydrochloride dex was used in. Dexmedetomidine is an alpha2agonist for shortterm sedation in critically ill patients. Dexmedetomidine hydrochloride injectionshould be administered only by persons skilled in the management of patients in the operating roo m setting. Persons with disabilities having problems accessing any of the pdf files below may call 2404023838 for assistance. Dexmedetomidine has no benefit on mechanical ventilation time when compared with the control group. Precedex dexmedetomidine hydrochloride pfizer canada.
Vials of dexdor and precedex contain a concentrate of dexmedetomidine hydrochloride, equivalent to 100 gml dexmedetomidine. Dexmedetomidine hydrochloride injection safely and. Due to the known pharmacological effects of dexmedetomidine hydrochloride injection, patients should be continuously monitored while receiving dexmedetomidine hydrochloride injection. Identification of the substancemixture and of the companyundertaking product name. Dexmedetomidine for sepsis in icu randomized evaluation trial desire the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Dexdomitor is stored in a 10 ml glass vial sealed with a coated rubber stopper and has a twoyear. Analgesic sublingual dexmedetomidine formulations and methods of use thereof are used to prevent, treat and control pain and other health problems. Therefore, the hplc method for the determination of related substances of dexmedetomidine impurity1 in dexmedetomidine hydrochloride injection is precise.
Six sample solutions of dexmedetomidine hydrochloride injection spiked with known impurity was prepared and injected into the hplc, along with standard solution. It is a very versatile drug in anaesthesia practice, finding place in increasing number of clinical scenarios and is no more limited to intensive care unit icu sedation. Dexmedetomidine is available in the united states for parenteral administration. Dexdomitor dexmedetomidine hydrochloride is a synthetic alpha 2adrenoreceptor agonist with sedative and analgesic properties. Dexmedetomidine hydrochloride 145108583 cayman chemical. Dexmedetomidine hydrochloride injection is a central alpha2 adrenergic agonist indicated for sedation of nonintubated patients prior to andor during surgical and other procedures.
A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. No further dilution of these preparations are necessary. Dexmedetomidine hydrochloride api dmfs us drug master. Dexmedetomidine hydrochloride injection infusion should not be coadministered through the same intravenous catheter with blood or plasma because physical compatibility has not been established.
When compared with propofol for sedation in the icu, dexmedetomidine may increase the length of hospital stay. The distribution halflife of dexmedetomidine is 6 minutes, and its terminal elimination halflife is 2 hours. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. Pdf dexmedetomidine hydrochloride as longterm sedative. Dexmedetomidine hydrochloride injection, concentrate dosage and administration dosing guidelines. Uchida et al 2019 induction of nonapoptotic cell death by adrenergic agonists in human oral squamous cell carcinoma cell lines.
Dexmedetomidine hydrochloride injection fresenius kabi usa, llc revision. It is a white, or almost white, crystalline, water soluble substance having a molecular weight of 236. Dexmedetomidine is an alpha 2 adrenergic receptor agonist, even ten times more selective than clonidine. Dexmedetomidine hydrochloride is a highly potent and selective.
Effects of dexmedetomidine hydrochloride on hemodynamics. Each 4 ml vial contains 400 micrograms of dexmedetomidine as hydrochloride. Listing a study does not mean it has been evaluated by the u. Dexmedetomidine hydrochloride monograph for professionals. Precedex is supplied as a clear, colorless, isotonic solution with a ph of 4. Pandharipande et al found that dexmedetomidine significantly increased mechanical ventilation time than the placebo group. Dexmedetomidine hydrochloride injection dosing should be individualized and titrated to desired. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pka of 7. Patients were randomized to one of two groups for sedation. Dexmedetomidine hydrochloride injection fda prescribing.
Selected citations for dexmedetomidine hydrochloride include. Dexmedetomidine hydrochloride injection has been shown to be incompatible when administered with the following drugs. The concentration of the final solution after dilution should be either 4 microgramsml or 8 microgramsml. Product monograph download pdf, 193kb patient information download pdf, 142kb product communication. For the april 12, 2016 meeting of the fdas pediatric advisory committee. Citations are publications that use tocris products. Dexmedetomidine for sepsis in icu randomized evaluation. Dexmedetomidinewhy should i make it a part of my anaesthetic practice. Highlights of prescribing information these highlights do not include all the information needed to use dexmedetomidine hydrochloride in 0. Dexmedetomidine premedication attenuates concanavalin ainduced hepatitis in mice.
See full prescribing information for dexmedetomidine hydrochloride. Precedex dexmedetomidine hydrochloride product information. On average, dexmedetomidine hydrochloridetreated patients received less morphine sulfate for pain than placebotreated patients 0. Cn103694175a new method for preparing dexmedetomidine. Ru2572692c2 dexmedetomidine sublingual compositions and.
793 17 1660 1207 1133 1480 193 883 1586 1378 1546 316 1687 101 662 1558 834 552 312 470 738 879 240 685 393 104 639 1262 1299 207 1472 1110 783 1363 294 930